Promising cancer treatment could be one step too far for rural Americans

Three years ago, the newlywed, then 62, was diagnosed with stage 4 lymphoma, sick from two failed chemotherapy cycles and sick of living in a trailer park near the MD Anderson Cancer Center in the University of Texas at Houston. It was the fall of 2019 and the treatment had forced her to migrate 750 miles east to rural New Mexico, where she had settled just months before her diagnosis.

Chimeric antigen receptor T-cell therapy might have been attractive to BeHanna if it had been available closer to home. But it is only offered in major transplant hospitals.

The therapy uses the patient’s T cells, a key part of the immune system, to fight the cancer. Dr. Michel Sadelain, an immunologist at Memorial Sloan Kettering Cancer Center in New York and a pioneer of the therapy, describes it as “a living drug – a T cell that has been weaponized against cancer.”

The treatment uses a process called apheresis to extract the patient’s T cells, then genetically alters the cells to add a receptor, the chimeric antigen, which binds to cancer cells.

Manufacturing CAR T cells takes about 10 days, but since only three companies – Bristol Myers Squibb, Gilead Sciences and Novartis – have FDA approval to produce them commercially, receiving cells for infusion can take up to a day. month. Once in the patient’s bloodstream, CAR T cells multiply, recognize cancer cells and kill them. If the therapy works, the patient’s cancer is usually in remission within a month.

For about 10 years, oncologists have been using CAR T-cell therapy in clinical trials for patients with blood cancers, including BeHanna, who has diffuse large B-cell lymphoma, and others with lymphoblastic leukemia. and multiple myeloma. But until recently, it was only FDA-approved for those who had already undergone two unsuccessful rounds of more conventional treatments, such as chemotherapy. For some types of blood cancer, treatment leads to remission in more than half of patients. In April, for the first time, the FDA approved CAR T-cell therapy for lymphoma patients whose cancer has come back within 12 months after a single course of more conventional treatment.

That more people are eligible for CAR T-cell therapy seems like good news, but Dr. Jason Westin, an oncologist at MD Anderson, isn’t immediately optimistic. Westin, chair of the American Society of Clinical Oncology’s government relations committee, fears that as more patients become eligible, the cost — $375,000 to $475,000 — will strain the ability of insurers to support it.

Patients who meet the FDA’s threshold for treatment are a relatively small group. “If it’s a very small fraction of patients who are getting expensive treatment, it’s hard on the system, but it might not be a stopping point,” Westin said. “But if you increase that slice of the pie for the patients who benefit from it, that starts to put more pressure on limited resources.”

Insurance companies, including Medicare, pay for CAR T-cell therapy, although according to the Leukemia & Lymphoma Society, they generally do not cover living expenses for patients who must live away from home, often for long periods of time. month. Blue Cross Blue Shield covered BeHanna’s medical expenses, but for living expenses she only reimbursed her $5,000, a small fraction of what she and her husband spent living in Houston.

And new research into using the technology to treat other cancers, autoimmune diseases and even infections could put pressure on the already limited supply chain.

There are other, less expensive ways to make CAR T cells besides going to a big pharmaceutical company. Many researchers working on clinical trials, including Dr. Michael Chu of the Cross Cancer Institute in Edmonton, Alberta, use a bread machine-sized bioreactor made by Miltenyi Biotec to modify T cells in the lab. Some medical centers have established in-house T-cell manufacturing platforms that use other bioreactors and protocols.

But the FDA hasn’t granted medical centers and academic institutions permission to manufacture the cells commercially, and neither Sadelain nor Westin expect that to happen any time soon, if at all. .

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Cost isn’t the only downside to CAR T-cell therapy. The Side effects can be life-threatening – about 2% of patients die as a result of treatment, according to Chu.

The most common side effect is a cytokine storm. Cytokines are small proteins that help direct the immune system, and their presence means the immune system is working. But sometimes the treatments send the immune system into overdrive, with results ranging from nausea and fever to organ failure.

The potentially toxic response to treatment has dictated where it can be administered. “If someone is having bad side effects, they need to be in a place that’s capable and set up to handle them,” Westin said. “A place used to giving treatment for breast cancer or lung cancer – they don’t know how to deal with what can potentially be a life-threatening side effect.”

For this reason, treatment is only available at approximately 150 transplant centerswhere specialists are available to oversee care, Westin said.
This creates an accessibility problem for about half American adults who live at least half an hour from the nearest transplant center. “These patients have been through so much,” Chu said. “Asking them to go just a little bit further is going too far in some cases, whether psychologically, financially or socially.”
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This was the case for BeHanna. She did not want to participate in another clinical trial. But her husband, Chris, had done so much work, first to learn about treatment and then to lobby his doctor. “He promised me that if it didn’t work out I could go home, and that was all I cared about,” she said. “I didn’t expect it to work.”

To make sure her T cells were healthy enough to be genetically modified, BeHanna had to undergo more chemo, which meant more time in Houston. Approximately one month elapsed between apheresis and the time the CAR T cells were ready to be infused. “By the time I got my cells back, I was really, really sick, and I didn’t care if it worked or not,” she said.

For the first few days after the infusion, BeHanna felt fine. But on the third or fourth day, when she was asked a series of routine questions that tested her neurological function, she was clearly suffering from neurotoxicity – a side effect that reverses in most patients. His temperature rose. The cytokine storm had begun. She was transferred from CAR T-cell to the intensive care unit.

When she woke up a few days later, lucid but weak, all she remembered was saying “a lot of mean and terrible things” to Chris.

BeHanna started crying as she described the first moments in the intensive care unit as she took her bearings and bent down to touch her stomach. “It was clear to me for the first time in as long as I can remember that I could touch my belly and it wasn’t difficult,” she said. “I could feel the tumor going away.”

Before the treatment, which she underwent in October 2019, a CT scan showed tumors all over her body: in her armpits, chest, abdomen and groin. At the end of November, around Thanksgiving, BeHanna had another scan.

“I didn’t have tumors,” she said. “It was surreal.”

BeHanna is grateful to be alive, but said she was frustrated that patients have to go through multiple rounds of harsh chemotherapy before they are allowed to continue treatment that could so effectively eliminate their cancer.

“CAR-T is a bit rough,” she said, but “it wasn’t hard for me because I can’t remember. It was something I was willing to risk because that you either do CAR-T or you’ll go home and die.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism on health issues. Along with policy analysis and polling, KHN is one of the three main operating programs of KFF (Kaiser Family Foundation). KFF is an endowed non-profit organization providing information on health issues to the nation.

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